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What’s the difference between prescription drugs and over-the-counter (OTC) drugs? Here are the biggest differences:

• Prescription drugs are prescribed for an intended use for one person by a doctor and purchased at a pharmacy.
• Over-the-counter drugs do not require a doctor’s prescription and are bought off-the-shelf in stores by anyone.
• Prescription drugs are regulated by the FDA through the New Drug Application (NDA) process which eventually leads to a standard manufacturer insert.
• Over-the-counter drugs are regulated by the FDA through OTC Drug monographs. Per the FDA, these are a kind of “recipe book” covering acceptable ingredients, doses, formulations, and labeling. If products conform to a monograph, then it can be marketed to the public without further FDA clearance. To find a monograph, click here.

For over-the-counter drugs labels, the FDA did require a nutrition-label type format for patients to easily read manufacturer instructions. If you are seeking informed consent for an over-the-counter drug, unfortunately the only information you might find is listed below:

Because of this, it is recommended to research any recent investigations, lawsuits, or recalls for the product you are researching as well as its active ingredient. Head to the next lesson to learn about how adverse reactions are reported for drugs.